商用临床化学试剂盒在马血清中的适用性。
Applicability of commercial clinical chemistry test kits for horse serum.
机构信息
Department of Biomedical Sciences, College of Veterinary Medicine and Agriculture, Addis Ababa University, Addis Ababa, Ethiopia.
Department of Biosystems, Division of Animal and Human Health Engineering, Laboratory of Host-Pathogen interaction, KU Leuven, Leuven, Belgium.
出版信息
BMC Res Notes. 2021 Jan 7;14(1):13. doi: 10.1186/s13104-020-05434-2.
OBJECTIVE
Validation of a test method is critical for confirming that the test can generate accurate and precise data. Although commercial biochemical test kits exist there are no specific and validated commercial clinical chemistry test kits designed for horses. The aim of this study was to validate commercial clinical chemistry test kits designed for a human serum for use in horses.
RESULTS
Blood samples were collected from 29 apparently healthy adult male horses and pooled serum was prepared. Validation comprises replication and recovery experiments. Total observable error (TE), sigma (σ) metrics, and quality goal index (QGI) were used to support the validation studies. Intra- and inter-assay variability was 2.05% and 2.08%, 2.26% and 1.89%, 2.4% and 1.63%, for total cholesterol, urea and total protein, respectively; recovery was 99.46%, 97.32%, and 100.1% for total cholesterol, urea and total protein, respectively. TE% for the specified analytes was within the total allowable error (TE). All three analytes satisfied the recommended requirement (> 3σ). The QGI for urea, as it had below 6σ was 0.95 indicating imprecision and inaccuracy. The results endorse the suitability of the studied commercial test kits and illustrated the acceptance criteria for horse's serum.
目的
验证测试方法对于确认测试可以生成准确和精确的数据至关重要。尽管存在商业生化测试试剂盒，但目前还没有专门针对马设计的经过验证的商业临床化学测试试剂盒。本研究的目的是验证专为人类血清设计的商业临床化学测试试剂盒是否可用于马。
结果
从 29 匹外观健康的成年雄性马中采集血液样本并混合血清。验证包括复制和恢复实验。总可观察误差 (TE)、西格玛 (σ) 指标和质量目标指数 (QGI) 用于支持验证研究。总胆固醇、尿素和总蛋白的内和间测定变异性分别为 2.05%和 2.08%、2.26%和 1.89%、2.4%和 1.63%；总胆固醇、尿素和总蛋白的回收率分别为 99.46%、97.32%和 100.1%。指定分析物的 TE% 在总允许误差 (TE) 范围内。所有三种分析物均满足推荐要求 (>3σ)。由于尿素的 QGI 低于 6σ，为 0.95，表明不精确和不准确。结果证明了所研究的商业测试试剂盒的适用性，并说明了马血清的接受标准。
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